- Merck & Co. (Rahway, NJ)
- …and apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence to industry standards.Lead risk ... Analysis (FMEA), implementing risk control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant… more
- Insmed Incorporated (NJ)
- …Oversee the CSV team, validation strategy and continuous process improvementEnsure compliance with GxP regulations and industry standardsFamiliarity with ... presenting to Executive Management and Boards of Directors .Strong understanding of risk management, compliance , and audit processes within regulated industries,… more
- Merck & Co. (Durham, NC)
- …process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance topics Perform routine risk communication pertaining to ... Management Systems (QMS), Quality Metrics, Quality Risk Assessment, Quality Risk Management, Regulatory Compliance Consulting {+ 5 more}Preferred Skills:… more
- Cipla (Central Islip, NY)
- …Relevant experience: Minimum of 10 years of procurement experience within the pharmaceutical or healthcare industry , with at least 3 years in a leadership role. ... performance and resolve any issues or disputes that may arise. Ensure compliance with regulatory requirements, industry standards, and company policies. Ensure… more
- Merck & Co. (Rahway, NJ)
- …and systems.The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to ... and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise wide… more
- Eisai, Inc (Nutley, NJ)
- …Cross-functional Influence, Critical Thinking & Business Agility, Drafting and Negotiation, Industry / Regulatory Knowledge, Legal & Reputational Risk Management, ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Merck & Co. (Rahway, NJ)
- …Device Development and with external suppliers. Understand and apply regulatory / compliance requirements relative to design controls and risk management ... and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying process… more
- Merck & Co. (Rahway, NJ)
- …globally.- The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to ... drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk … more
- Cipla (Fall River, MA)
- …member of the InvaGen Pharmaceuticals Plant Quality Team. This role ensures compliance with both internal and external quality standards at Invagen Pharmaceuticals ... remains compliant with all regulatory requirements (eg, FDA, ICH, EMA). Support risk assessments and help mitigate any potential quality risks to product safety… more
- Merck & Co. (Durham, NC)
- …Assurance (SFQA) B160 to support process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial ... all aspects of the Shop Floor QA proceed in compliance with cGMP, regulations, and our Company's Quality Management...engineering discipline with five (5) years in the pharmaceutical industry or highly regulated industry . OR Master's… more
